Effect of Flovent Discus vs QVAR vs Pulmicort Flexhaler on Short Term Growth

• Sponsor: West Penn Allegheny Health System (Other)
• Overall Status: Completed
• CT.gov ID: NCT01520688
• Collaborator: (none)
• Enrollment: 32
• Locations: 2
• Arms: 6
• Duration (Months): 48
• Patients Per Site: 16
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

Children with mild persistent asthma that have asthma symptoms once or twice a week and use a daily controller, while children with mild intermittent asthma rarely have asthma symptoms and do not use a daily controller. Inhaled corticosteroids are the standard treatment for mild peristent asthma. The purpose of this study is to measure children rate of growth while on different inhaled corticosteroids.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: Fluticasone, Budesonide, Beclomethasone; Drug: Fluticasone, Beclomethasone, Budesonide; Drug: Budesonide, Fluticasone, Beclomethasone; Drug: Budesonide, Beclomethasone, Fluticasone; Drug: Beclomethasone, Fluticasone, Budesonide; Drug: Beclomethasone, Budesonide, Fluticasone	Phase 4

Detailed Description

A randomized, cross over study evaluating the effect of Flovent Discus 100 mcg BID vs QVAR 80 mcg BID vs Pulmicort Flexhaler 180 mcg BID on short term growth in pediatric subjects with asthma.

Objectives:

1. The primary objective of this study is to compare the effect of Flovent Diskus 100 mcg BID versus Pulmicort Flexhaler 180 mcg BID on short-term lower leg growth velocity as measured by knemometry in pediatric subjects with mild asthma.

2. The secondary objective of this study is to compare the effect of Flovent Diskus 100 mcg BID versus QVAR 80 mcg BID on short-term lower leg growth velocity as measured by knemometry in pediatric subjects with mild asthma.

Aims:

1. The primary aim is to show that there is a growth suppressive effect of Pulmicort Flexhaler 180 mcg BID versus Flovent Diskus 100 mcg BID in children with mild asthma.

2. The secondary aim to show that there is a growth suppressive effect of QVAR 80 mcg BID versus Flovent Diskus 100 mcg BID in children with mild asthma.

Hypotheses:

1. The primary hypothesis is that treatment with Pulmicort Flexhaler 180mcg BID as compared to Flovent Diskus 100 mcg BID has a growth suppressive effect on lower leg length as assessed by knemometry in pediatric subjects with mild asthma.

2. The secondary hypothesis is that treatment with QVAR 80 mcg BID as compared to Flovent Diskus 100 mcg BID has a growth suppressive effect on lower leg length as assessed by knemometry in pediatric subjects with mild asthma.

Study Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized, Cross Over Study Evaluating the Effect of Flovent Discus 100 mcg BID vs QVAR 80 mcg BID vs Pulmicort Flexhaler 180 mcg BID on Short Term Growth in Pediatric Subjects With Asthma
• Study Start Date: Feb 1, 2012
• Actual Primary Completion Date: Feb 1, 2016
• Actual Study Completion Date: Feb 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Treatment Sequence, FPQ Period 2 Flovent Diskus Period 4 Pulmicort Flexhaler Period 6 QVAR	Drug: Fluticasone, Budesonide, Beclomethasone; Fluticasone 100 mcg bid Budesonide 180 mcg bid Beclomethasone 80 mcg bid; Other Names: Flovent Diskus Pulmicort Flexhaler QVAR
Experimental: 2 Treatment Sequence, FQP Period 2 Flovent Diskus Period 4 QVAR Period 6 Pulmicort	Drug: Fluticasone, Beclomethasone, Budesonide; Fluticasone 100mcg BID Beclomethasone 80 mcg BID Budesonide 180 mcg BID; Other Names: Flovent Diskus Pulmicort Flexhaler QVAR
Experimental: 3 Treatment Sequence, PFQ Period 2 Pulmicort Period 4 Flovent Period 6 QVAR	Drug: Budesonide, Fluticasone, Beclomethasone; Budesonide180 mcg BID Fluticasone 100 mcg Beclomethasone 80 mcg BID; Other Names: Pulmicort Flexhaler Flovent Diskus QVAR
Experimental: 4-Treatment Sequence, PQF Period 2 Pulmicort Period 4 QVAR Period 6 Flovent	Drug: Budesonide, Beclomethasone, Fluticasone; Budesonide 180 mcg BID Beclomethasone 80mcg BID Fluticasone 100mcg BID; Other Names: Pulmicort Flexhaler QVAR Flovent Diskus
Experimental: 5 Treatment Sequence, QFP Period 2 QVAR Period 4 Flovent Period 6 Pulmicort	Drug: Beclomethasone, Fluticasone, Budesonide; Beclomethasone 80 mcg BID Fluticasone 100mcg BID Budesonide 180 mcg BID; Other Names: QVAR Flovent Diskus Pulmicort Flexhaler
Experimental: 6 Treatment Sequence, QPF Period 2 QVAR Period 4 Pulmicort Period 6 Flovent	Drug: Beclomethasone, Budesonide, Fluticasone; Beclomethasone 80mcg BID Budesonide 180 mcg BID Fluticasone 100mcg BID; Other Names: QVAR Pulmicort Flexhaler flovent Diskus

Outcome Measures

Primary Outcome Measures

1. Short-term Lower Leg Growth During Treatment With Flovent Diskus 100 mcg BID or Pulmicort Flexhaler 180 mcg BID. [1 yr]

   Short-term lower leg growth as assessed by knemometry in pediatric subjects with mild asthma treated with Flovent Discus 100 mcg BID or Pulmicort Flexhaler 180 mcg BID.

Secondary Outcome Measures

1. Short-term Lower Leg Growth During Treatment With Flovent Discus 100 mcg BID or QVAR 80 mcg BID. [1 yr]

   Short-term lower leg growth as assessed by knemometry in pediatric subjects with mild asthma during treatment with Flovent Discus 100 mcg BID or QVAR 80 mcg BID.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 11 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Subjects will include females (6 to 9 years of age) and males (6 to 11 years of age).

2. All subjects must have a history of physician diagnosed mild intermittent or mild persistent asthma as documented by PCP medical record or detailed history by study investigator.

3. All subjects must have a height within normal limits (5th to 95th percentile) and no history of abnormal growth as assessed by medical history.

4. All subjects must be pre-pubertal (Tanner Stage 1 Sexual Maturity) as assessed by physical examination.

5. Subjects may be on current treatment with montelukast as this drug does not affect growth. If a subject is on montelukast at screening/baseline, they will remain on a stable dose throughout the study.

6. Subjects must be willing to comply with study requirements.

Exclusion Criteria:

1. Subjects will be excluded if they have asthma greater than mild persistent severity as defined by NHLBI guidelines.

2. Subjects will be excluded if they used any systemic or nasal steroids within the past 60 days.

3. Subjects will be excluded if they had more than one burst of systemic steroids within the past year.

4. Subjects will be excluded if their baseline FEV1 is < 80% predicted.

5. Subjects will be excluded if they have any other serious systemic disease other than asthma.

6. Subjects will be excluded if they have taken any medication known to affect growth i.e. ADHD medications within the past 60 days

7. Subjects will be excluded if they have a history of allergy to any of the study medications, milk protein or lactose.

8. Subjects will be excluded if they have active chickenpox or measles or recent exposure to chickenpox or measles.

9. Subjects will be excluded if they have any history of tuberculosis of the respiratory tract.

10. Subjects will be excluded if they have any active fungal, bacterial, viral or parasitic infections.

11. Subjects will be excluded if they have any history of herpes simplex infection of the eye.

12. Subjects will be excluded if they have taken any immunosuppressive drugs within the past 2 months.

13. Subjects will be excluded if they have any history of Churg-Strauss syndrome or other eosinophilic disorders.

14. Subjects will be excluded if an investigator deems they have any mental or development health issues, such as autism, moderate to severe mental retardation or severe ADHD,that interferes with their ability to complete the knemometry measurements.

15. Subjects will be excluded if an investigator deems they have any physical issues, such as inability to sit independently or amputation of lower leg, that interferes with their ability to complete the knemometry measurements.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pediatric Alliance-Greentree Division	Green Tree	Pennsylvania	United States	15220
2	Allegheny General Hospital	Pittsburgh	Pennsylvania	United States	15212

Sponsors and Collaborators

• West Penn Allegheny Health System

Investigators

• Principal Investigator: Deborah A Gentile, MD, Allegheny Singer Research Institute/Allegheny General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Deborah Gentile, Principal Investigator, West Penn Allegheny Health System
• ClinicalTrials.gov Identifier: NCT01520688
• Other Study ID Numbers: RC#5255
• First Posted: Jan 30, 2012
• Last Update Posted: Nov 18, 2020
• Last Verified: Oct 1, 2020

• Keywords provided by Deborah Gentile, Principal Investigator, West Penn Allegheny Health System: Mild persistent or mild intermittent asthma
• Additional relevant MeSH terms: Asthma; Fluticasone; Xhance; Budesonide; Beclomethasone

Study Results

Participant Flow

Arm/Group Title	1 Treatment Sequence, FPQ	2 Treatment Sequence, FQP	3 Treatment Sequence, PFQ	4-Treatment Sequence, PQF	5 Treatment Sequence, QFP	6 Treatment Sequence, QPF	Enrolled But Not Randomized.
Arm/Group Description	Period 2 Flovent Diskus Period 4 Pulmicort Flexhaler Period 6 QVAR Fluticasone, Budesonide, Beclomethasone: Fluticasone 100 mcg bid Budesonide 180 mcg bid Beclomethasone 80 mcg bid	Period 2 Flovent Diskus Period 4 QVAR Period 6 Pulmicort Fluticasone, Beclomethasone, Budesonide: Fluticasone 100mcg BID Beclomethasone 80 mcg BID Budesonide 180 mcg BID	Period 2 Pulmicort Period 4 Flovent Period 6 QVAR Budesonide, Fluticasone, Beclomethasone: Budesonide180 mcg BID Fluticasone 100 mcg Beclomethasone 80 mcg BID	Period 2 Pulmicort Period 4 QVAR Period 6 Flovent Budesonide, Beclomethasone, Fluticasone: Budesonide 180 mcg BID Beclomethasone 80mcg BID Fluticasone 100mcg BID	Period 2 QVAR Period 4 Flovent Period 6 Pulmicort Beclomethasone, Fluticasone, Budesonide: Beclomethasone 80 mcg BID Fluticasone 100mcg BID Budesonide 180 mcg BID	Period 2 QVAR Period 4 Pulmicort Period 6 Flovent Beclomethasone, Budesonide, Fluticasone: Beclomethasone 80mcg BID Budesonide 180 mcg BID Fluticasone 100mcg BID	These subjects were consented but not randomized.
Period Title: Overall Study
STARTED	4	4	4	5	5	5	5
COMPLETED	4	2	4	4	4	5	0
NOT COMPLETED	0	2	0	1	1	0	5

Baseline Characteristics

Arm/Group Title	All Study Participants
Arm/Group Description
Overall Participants	27
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	8.4 (1.57)
Sex: Female, Male (Count of Participants)
Female	5 18.5%
Male	22 81.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	2 7.4%
White	25 92.6%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
United States	27 100%

Outcome Measures

1. Primary Outcome

Title	Short-term Lower Leg Growth During Treatment With Flovent Diskus 100 mcg BID or Pulmicort Flexhaler 180 mcg BID.
Description	Short-term lower leg growth as assessed by knemometry in pediatric subjects with mild asthma treated with Flovent Discus 100 mcg BID or Pulmicort Flexhaler 180 mcg BID.
Time Frame	1 yr

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Flovent Discus 100 mcg BID	Pulmicort Flexhaler 180 mcg BID
Arm/Group Description
Measure Participants	27	27
Mean (95% Confidence Interval) [mm/wk]	0.37	0.21

2. Secondary Outcome

Title	Short-term Lower Leg Growth During Treatment With Flovent Discus 100 mcg BID or QVAR 80 mcg BID.
Description	Short-term lower leg growth as assessed by knemometry in pediatric subjects with mild asthma during treatment with Flovent Discus 100 mcg BID or QVAR 80 mcg BID.
Time Frame	1 yr

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Flovent Discus 100 mcg BID	QVAR 80 mcg BID
Arm/Group Description
Measure Participants	27	27
Mean (95% Confidence Interval) [mm/wk]	0.37	0.38

Adverse Events

Arm/Group Title	Flovent Discus 100 mcg BID		Pulmicort Flexhaler 180 mcg BID		QVAR 80 mcg BID
Arm/Group Description
All Cause Mortality
	Flovent Discus 100 mcg BID		Pulmicort Flexhaler 180 mcg BID		QVAR 80 mcg BID
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/27 (0%)		0/27 (0%)		0/27 (0%)
Serious Adverse Events
	Flovent Discus 100 mcg BID		Pulmicort Flexhaler 180 mcg BID		QVAR 80 mcg BID
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/27 (0%)		0/27 (0%)		0/27 (0%)
Other (Not Including Serious) Adverse Events
	Flovent Discus 100 mcg BID		Pulmicort Flexhaler 180 mcg BID		QVAR 80 mcg BID
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/27 (25.9%)		6/27 (22.2%)		7/27 (25.9%)
Ear and labyrinth disorders
Ear infection	0/27 (0%)		0/27 (0%)		1/27 (3.7%)
General disorders
Colds/viral illnesses	7/27 (25.9%)		6/27 (22.2%)		7/27 (25.9%)
Headaches	2/27 (7.4%)		3/27 (11.1%)		3/27 (11.1%)
Bodily injuries	1/27 (3.7%)		1/27 (3.7%)		0/27 (0%)
Sinus infection	0/27 (0%)		0/27 (0%)		1/27 (3.7%)
Immune system disorders
Worsening allergies	1/27 (3.7%)		0/27 (0%)		1/27 (3.7%)
Asthma exacerbation	1/27 (3.7%)		0/27 (0%)		0/27 (0%)
Respiratory, thoracic and mediastinal disorders
Respiratory infections	2/27 (7.4%)		3/27 (11.1%)		0/27 (0%)
Pneumonia	1/27 (3.7%)		0/27 (0%)		0/27 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.